Theraflu Flu Relief Max Strength
- Product NDC
- 0067-8205
- 11-digit product format
- 000678205
- Labeler code
- 0067
- Product ID
- 0067-8205_446e5d67-95c9-e039-e063-6294a90a6cfa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-06-27
- Substance
- ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 1000; 4; 30 mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Theraflu Flu Relief Max Strength
- Brand name suffix
- Nighttime
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 1000 mg/30mL |
| CHLORPHENIRAMINE MALEATE | 4 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| V1Q0O9OJ9Z | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2604562 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 780907b8-34ba-4ec8-bcdf-b2a31bd111df | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-8205-01 | Theraflu Flu Relief Max StrengthNighttime | 245.5 mL in 1 BOTTLE | SYRUP | 245.5 | 5 | |
| 0067-8205-01 | Theraflu Flu Relief Max StrengthDaytime Nighttime Value Pack | 245.5 mL in 1 BOTTLE | SYRUP | 245.5 mL | 30 mg in 30mL | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0067-8205-01 | ML - Milliliter | 0067-8205 | 4caa04a4-1310-43be-828c-7d6dca78e82a | 1 | 2025-12-16 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-8205 | THERAFLU FLU RELIEF MAX STRENGTH NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) SYRUP [HALEON US HOLDINGS LLC] | 4 | Current NDC, 1 package rows | 20250115_780907b8-34ba-4ec8-bcdf-b2a31bd111df.zip |
| 0067-8205 | THERAFLU FLU RELIEF MAX STRENGTH DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) KIT [HALEON US HOLDINGS LLC] | 3 | Current NDC | 20240310_3618ccf0-1f30-42e0-bb50-bfa45cf2b583.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Black Cherry Cough Drops | MENTHOL | Boston Nutraceutical Production SL | 856f2e1a-2593-99e6-e053-2991aa0ad039 | 2024-10-07 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Boston Nutraceutical Production SL | 857363b6-e025-e074-e053-2a91aa0a4379 | 2024-10-07 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Boston Nutraceutical Production SL | 857365ba-895e-4a63-e053-2991aa0a8b9f | 2024-10-07 | Warnings | M012 |
| Menthol Vapor Cough Drops | MENTHOL | BOSTON NUTRACEUTICAL PRODUCTION, S.L | a7062db1-8201-b400-e053-2a95a90a55e8 | 2024-10-07 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Boston Nutraceutical Production SL | b8f48a47-6871-f7ed-e053-2995a90a16f3 | 2024-10-07 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Boston Nutraceutical Production SL | 856f0bd8-354b-a002-e053-2a91aa0a8022 | 2024-10-07 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Boston Nutraceutical Production SL | 83c4928a-eea6-e176-e053-2991aa0a6bb1 | 2024-10-07 | Warnings | M012 |
| Natural Herbal Cough Drops | MENTHOL | BOSTON NUTRACEUTICAL PRODUCTION, S.L | c2340f56-9a8e-4eea-e053-2995a90a78fc | 2024-10-07 | Warnings | M012 |
| Natural Herbal Cough Drops | MENTHOL | BOSTON NUTRACEUTICAL PRODUCTION, S.L | a706ee9c-9ed0-d3f1-e053-2a95a90a26d6 | 2024-10-07 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | eff0b37b-6c08-b687-e053-2a95a90a11a9 | 2024-10-07 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | Topco Associates LLC | efcf2edd-21a3-45f9-e053-2995a90a3865 | 2024-10-07 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | eff65505-8846-35c2-e053-2a95a90a6b79 | 2024-10-07 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | Topco Associates LLC | eff0fdfe-695a-4e62-e053-2a95a90ab50f | 2024-10-07 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | eff1a70f-fa71-52b2-e053-2995a90a038c | 2024-10-07 | Warnings | M012 |
| Honey Lemon Menthol Cough Drops | HONEY LEMON MENTHOL | Topco Associates LLC | f5be283b-524d-26af-e053-2995a90a3972 | 2024-10-07 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | eff16ba3-7e30-aa93-e053-2995a90a64cb | 2024-10-07 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Target Corporation Inc. | ebf6bcf5-9384-052a-e053-2a95a90a30a5 | 2024-10-07 | Warnings | M012 |
| Rompe Pecho SF Flu SF Flu | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Efficient Laboratories Inc | 06eac696-e8f6-ac50-e063-6394a90a2ed6 | 2024-10-07 | Warnings | M012 |
| dg health nasal four | PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, LLC | ceeeb016-8e46-40b8-9923-8a4270475f45 | 2024-10-04 | Warnings | M012 |
| Topcare Nasal Four | PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 99bc8829-167b-4cf8-8421-57da369f24cd | 2024-10-04 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2604562 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution | PSN | 780907b8-34ba-4ec8-bcdf-b2a31bd111df | 5 |
| 2604562 | acetaminophen 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution | SCD | 780907b8-34ba-4ec8-bcdf-b2a31bd111df | 5 |
| 2604562 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG per 30 mL Oral Solution | SY | 780907b8-34ba-4ec8-bcdf-b2a31bd111df | 5 |
| 2604562 | APAP 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution | SY | 780907b8-34ba-4ec8-bcdf-b2a31bd111df | 5 |
| 2604635 | {1 (acetaminophen 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution) / 1 (acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution) } Pack | GPCK | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 2604635 | 1 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution) / 1 daytime (acetaminophen 1000 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution) Pack | PSN | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 2604562 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution | PSN | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 1359455 | acetaminophen 500 MG / dextromethorphan HBr 15 MG in 15 mL Oral Solution | PSN | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 2604562 | acetaminophen 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution | SCD | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 1359455 | acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution | SCD | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 2604635 | 1 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution) / 1 daytime (acetaminophen 1000 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution) Pack | SY | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 2604635 | 1 nighttime (acetaminophen 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan HBr 1 MG/ML Oral Solution) / 1 daytime (acetaminophen 33.3 MG/ML / dextromethorphan HBr 1 MG/ML Oral Solution) Pack | SY | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 2604562 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG per 30 mL Oral Solution | SY | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 1359455 | acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG per 30 ML Oral Solution | SY | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 1359455 | acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral Solution | SY | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 2604562 | APAP 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution | SY | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 1359455 | APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Solution | SY | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0067-8205-01 | 00067820501 | 245.5 mL in 1 BOTTLE (0067-8205-01) | 245.5 ml | 2022-06-27 | No | No | Current |